Ruxolitinib Cream for Discoid Lupus

Recruiting at 2 trial locations

Overseen By Fareheen Chowdhury

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Innovaderm Research Inc.

Must not be taking: Topical corticosteroids, Retinoids

Disqualifiers: Pregnancy, Skin disease, Immune deficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called ruxolitinib (Opzelura), which might help people with discoid lupus erythematosus (DLE), a skin condition causing red, scaly patches. Researchers aim to determine if different application methods enhance the cream's effectiveness. Those diagnosed with moderate to severe DLE might find this trial suitable. Participants must follow all study procedures and remain available throughout the study period. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.

Do I have to stop taking my current medications?

The trial requires that you stop using any topical medicated treatments that could affect discoid lupus erythematosus (DLE) within 2 weeks before starting the study. This includes topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices. Additionally, you must not have received any biological agents within 12 weeks or 5 half-lives before the study. The protocol does not specify other medications, so it's best to discuss with the study team.

Will I have to stop taking my current medications?

The trial requires that you stop using any topical medicated treatments that could affect discoid lupus erythematosus (DLE) within 2 weeks before starting the study. Additionally, you must not have used any biological agents within 12 weeks or certain investigational products within 4 weeks before the study begins.

Is there any evidence suggesting that ruxolitinib 1.5% cream is likely to be safe for humans?

Research has shown that ruxolitinib cream is generally safe for people. Studies have found it to be well tolerated, with side effects similar to those of a placebo cream, meaning any side effects are usually mild to moderate. The cream absorbs very little into the bloodstream, reducing the risk of serious side effects.

Ruxolitinib cream has already received approval for treating another skin condition, indicating that it meets safety standards for human use. However, its safety and effectiveness for treating discoid lupus remain under investigation.

Overall, early findings suggest that ruxolitinib cream is safe for use on the skin, with a low chance of major side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ruxolitinib cream is unique because it offers a targeted approach for treating discoid lupus, a condition that typically relies on topical corticosteroids or antimalarials. Unlike these standard treatments, which can have broad effects, ruxolitinib cream specifically inhibits the JAK1/2 pathways, which are involved in inflammation and immune responses. This selective action allows for potentially fewer side effects and more focused treatment of the skin lesions. Additionally, the cream's flexible application—either with or without occlusion—provides versatility in managing the condition, potentially leading to better patient outcomes.

What evidence suggests that ruxolitinib cream might be an effective treatment for discoid lupus?

Research has shown that ruxolitinib 1.5% cream may help treat discoid lupus erythematosus (DLE), a skin condition. Studies have found that this cream can improve skin lesions, which are common in people with lupus. One study noted improvements in disease activity and redness when patients used the cream. Although the study did not find a significant change in pain or itchiness, the cream still showed potential benefits. Early findings suggest it might help manage symptoms in people with DLE. Participants in this trial will apply ruxolitinib 1.5% cream in different sequences to evaluate its effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

Robert Bissonnette, MD

Principal Investigator

Innovaderm Research Inc.

Are You a Good Fit for This Trial?

This trial is for adults with discoid lupus erythematosus, a chronic skin condition. Participants should have stable disease and be willing to apply cream treatments as directed. Specific eligibility details are not provided, but typically trials exclude those with certain health conditions or who are taking conflicting medications.

Inclusion Criteria

Subjects must be willing to comply with all study procedures and must be available for the duration of the study

I am a woman who can have children and have tested negative for pregnancy.

I am willing and able to give my consent to participate in the study.

Exclusion Criteria

Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening

Subject is known to have immune deficiency or is immunocompromised

Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply ruxolitinib 1.5% cream twice daily on active lesions for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ruxolitinib 1.5% Cream

Trial Overview The study tests the effectiveness of Ruxolitinib 1.5% cream in treating discoid lupus erythematosus. It's a single-blind study where participants use the cream normally on some lesions and under occlusion (covered) at night on others to compare results.

How Is the Trial Designed?

Group I: ruxolitinib 1.5% cream (Sequence 1) Experimental Treatment 3 Interventions

ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2

Group II: ruxolitinib 1.5% cream ( Sequence 2) Experimental Treatment 3 Interventions

ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2

Ruxolitinib 1.5% Cream is already approved in United States, European Union for the following indications:

Approved in United States as Opzelura for:

• Atopic dermatitis
• Nonsegmental vitiligo

Approved in European Union as Opzelura for:

• Atopic dermatitis
• Nonsegmental vitiligo

Who Is Running the Clinical Trial?

Innovaderm Research Inc.

Lead Sponsor

Trials

49

Recruited

3,200+

Published Research Related to This Trial

Ruxolitinib (Opzelura) has been approved by the FDA as a topical treatment for nonsegmental vitiligo in individuals aged 12 and older, indicating its efficacy for this skin condition.

The most common side effects reported include application site acne, itching, and redness, as well as other mild issues like headaches and urinary tract infections, suggesting that while generally safe, users should be aware of these potential reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Indication for Topical Ruxolitnib. Aschenbrenner, DS.[2023]

In a case study of two patients with severe discoid lupus erythematosus (DLE) resistant to standard treatments, low-dose lenalidomide (5 mg/d) led to significant clinical improvement in one patient within one month, which was sustained for 10 months before dosage adjustment.

While lenalidomide shows promise as an alternative treatment for refractory DLE, it can cause mild neutropenia, necessitating careful monitoring of blood cell counts, and its efficacy was not observed in the second patient, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide for the treatment of resistant discoid lupus erythematosus. Shah, A., Albrecht, J., Bonilla-Martinez, Z., et al.[2021]

In two phase 3 trials involving 1249 patients with atopic dermatitis, ruxolitinib cream showed rapid and significant reductions in itch, with over 16% of patients experiencing a 2-point reduction within 12 hours compared to only 6.9% with the vehicle cream.

By Day 2, a greater percentage of patients using ruxolitinib cream achieved a 4-point reduction in itch severity, with sustained improvements observed over the 8-week treatment period, indicating both efficacy and a quick onset of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. Blauvelt, A., Kircik, L., Papp, KA., et al.[2023]

Ruxolitinib cream, a topical treatment for atopic dermatitis, was found to be generally well tolerated in a study of 41 patients aged 12 to 65, with only 31.7% experiencing treatment-emergent adverse events, and only 9.8% reporting treatment-related adverse events.

The cream demonstrated high efficacy, with 94.6% of patients achieving at least a 75% improvement in their eczema severity after 56 days of treatment, while the mean plasma concentration of the drug remained well below levels that could cause harmful effects on bone marrow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. Bissonnette, R., Call, RS., Raoof, T., et al.[2022]

In phase II clinical trials, patients using 1.5% topical ruxolitinib (RUX) showed a significant improvement in Eczema Area and Severity Index (EASI) scores after 4 weeks, with a mean improvement of 71.6% compared to only 15.5% for the placebo group (P < 0.001).

Phase III trials demonstrated that a higher percentage of patients treated with 0.75% and 1.5% topical RUX achieved clear or almost clear skin (IGA score of 0 or 1) after 8 weeks, significantly outperforming the placebo (15.1% and 7.6% respectively, P < 0.001), indicating its efficacy in managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Ruxolitinib in the Treatment of Atopic Dermatitis. Mohney, LA., Singh, R., Feldman, SR.[2023]

In a clinical trial involving 41 patients with labial discoid lupus erythematosus, both tacrolimus 0.03% ointment and triamcinolone acetonide 0.1% cream showed similar efficacy, with complete response rates of 70% and 89.5% respectively, indicating that tacrolimus is as effective as the standard treatment.

Tacrolimus demonstrated a significantly greater reduction in reticulation areas and pain scores compared to triamcinolone, with minimal side effects reported, suggesting it is a safe and effective alternative for managing labial DLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus 0.03% ointment in labial discoid lupus erythematosus: A randomized, controlled clinical trial. Wang, X., Zhang, L., Luo, J., et al.[2015]

In a case study of a patient with generalized discoid lupus erythematosus resistant to multiple conventional treatments, the addition of rapamycin resulted in a positive treatment response within 6 weeks, demonstrating its potential efficacy.

Rapamycin was well-tolerated with no adverse effects reported, suggesting it may be a safe alternative for patients with severe cases of discoid lupus erythematosus who do not respond to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapamycin for refractory discoid lupus erythematosus. Herold, M., Richmond, NA., Montuno, MA., et al.[2019]

In two phase 3 studies involving 1249 patients with atopic dermatitis, ruxolitinib cream significantly improved treatment outcomes compared to a vehicle cream, with 93.4% of patients using the 0.75% formulation and 90.9% using the 1.5% formulation achieving clinically meaningful responses by week 8.

Patients who continued using ruxolitinib cream beyond 8 weeks showed progressive improvements, with over half achieving treatment success by week 52, indicating that extended therapy can provide additional benefits and that the cream was well tolerated throughout the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically relevant improvements in adults and adolescents with atopic dermatitis who did not achieve Investigator's Global Assessment treatment success following 8 weeks of ruxolitinib cream monotherapy. Simpson, EL., Kircik, L., Blauvelt, A., et al.[2023]

Ruxolitinib cream 1.5% significantly improved disease severity, itching, and sleep disturbance in patients aged 12 and older with mild to moderate atopic dermatitis after 8 weeks of treatment, and continued to control symptoms for an additional 44 weeks when applied as needed.

The cream was well tolerated, with a safety profile similar to that of a placebo, and infrequent local side effects, making it a promising alternative to traditional treatments like corticosteroids for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. Hoy, SM.[2023]

An open-label phase 2 pilot study evaluated the efficacy of oral tofacitinib in treating adult patients with Discoid Lupus Erythematosus (DLE), indicating its potential as a therapeutic option for this condition.

The study suggests that tofacitinib may improve skin lesions associated with DLE, although further research is needed to confirm its safety and effectiveness in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-Label Phase 2 Pilot Study of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE). Alsukait, S., Learned, C., Rosmarin, D.[2023]

In a study involving 38 patients with cutaneous lupus erythematosus (CLE), topical calcineurin inhibitors (tacrolimus and pimecrolimus) significantly improved clinical symptoms like erythema, desquamation, and edema over 60 days, whether used alone or with hydroxychloroquine.

The combination treatment with hydroxychloroquine led to a 100% improvement in edema among patients, while monotherapy with calcineurin inhibitors resulted in a 75% improvement, highlighting their effectiveness in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of topical calcineurin inhibitors as monotherapy or in combination with hydroxychloroquine in cutaneous lupus erythematosus. Avgerinou, G., Papafragkaki, DK., Nasiopoulou, A., et al.[2014]

Topical ruxolitinib has been shown to improve various dermatological conditions, including atopic dermatitis, vitiligo, psoriasis, and lichen planus, based on a review of 24 studies involving 2618 patients.

The safety profile of topical ruxolitinib is favorable, with minimal bioavailability and low rates of mild-to-moderate side effects, making it a more tolerable option compared to systemic Janus kinase inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Topical Ruxolitinib in Dermatology: A Review. Kashetsky, N., Turchin, I.[2023]

In a phase II study involving 12 patients, topical ruxolitinib significantly reduced the total lesion count in cutaneous lichen planus by a median of 50 lesions after 8 weeks of treatment, indicating its efficacy.

Transcriptomic analysis revealed that cutaneous lichen planus is driven by interferon pathways, and the treatment with ruxolitinib led to downregulation of interferon-stimulated genes, supporting its mechanism of action in targeting this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. Brumfiel, CM., Patel, MH., Severson, KJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04908280

NCT04908280 | Study of Ruxolitinib Cream for the ... The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9494033/

Treatment of cutaneous lupus with topical ruxolitinib cream Ruxolitinib has been shown to control skin lesions in a case of chilblain lupus erythematosus and topical tofacitinib was effective in treating a case of ...

3. jidonline.org jidonline.org/article/S0022-202X(24)01565-3/fulltext

LB935 Ruxolitinib cream for discoid lupus erythematosus There was a reduction, but no statistically significant change, in the mean NRS for pain (1.2 vs 0.67, scale 0-10) or pruritus (2.8 vs 0.0, scale 0-10), likely ...

4. ovid.com ovid.com/journals/jaade/pdf/10.1016/j.jaad.2024.11.036~ruxolitinib-cream-for-discoid-lupus-erythematosus-an

Ruxolitinib cream for discoid lupus erythematosus Ruxolitinib 1.5% cream led to improvement in both the primary outcome measure (IGA) and sec- ondary outcome measures of disease activity (CLASI-. A and erythema ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06261021

Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in ... This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

6. withpower.com withpower.com/trial/ruxolitinib-cream-for-discoid-lupus-6f62f

Ruxolitinib Cream for Discoid Lupus In studies, it was well tolerated with a safety profile similar to vehicle cream, showing minimal bioavailability and low rates of mild-to-moderate treatment- ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/215309s007lbl.pdf

OPZELURA® (ruxolitinib) cream, for topical use The safety and effectiveness of OPZELURA have not been established in pediatric patients younger than 2 years of age with atopic dermatitis. Nonsegmental ...